Transplantation of Pancreatic Islets in Patients With Type 1 Diabetes Mellitus and Functional Kidney Graft (GRAGIL1)

May 28, 2010 updated by: University Hospital, Grenoble

Transplantation d'îlots pancréatiques allogéniques Adultes Pour le Traitement du diabète insulinodépendant. Etude GRAGIL 1

This research project is supported by a multicentric network of collaborators whose goal is to assess the efficacy of transplanting allogenic pancreas islets to restore insulin secretion in patients with type 1, insulin-dependent diabetes mellitus with kidney transplantation and to improve their metabolic control.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The main objective is to demonstrate the beneficial effect of islet allotransplantation in patients with type 1 diabetes with no endogenous insulin secretion, and with a functional kidney graft. The other objectives are to evaluate the conditions for the efficacy of islet cell transplantation, to assess the improvement in quality of life and the cost of the islet cell transplantation.

Study Type

Interventional

Enrollment (Anticipated)

21

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France, 25000
        • University Hospital
      • Grenoble, France, 38043
        • University Hospital, Department of Endocrinology
      • Lyon, France, 69000
        • University Hospital, Department of Endocrinology
      • Montpellier, France, 34000
        • University Hospital, Department of Endocrinology
      • Nancy, France, 54000
        • University Hospital, Department of Endocrinology
      • Strasbourg, France, 66000
        • University Hospital, Department of Endocrinology
  • Switzerland
      • Geneva, Switzerland, 1211
        • University Hospital, Department of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 diabetes mellitus
  • Disease duration > 5 years
  • ketose antecedents
  • Basal and stimulated plasma C-< 0.2 ng/ml,<0.06 nmol/l (glycemia must be measured simultaneously_ 1.20 g/l or 6.6 mM, stimulation with glucagon IV 1 mg -Measured at à T0 and T 6 min)
  • Established kidney graft ≥ 6 months
  • Current creatinine clearance: ≥ 50 ml/min/1.73 m² and Proteinuria < 0.5 g/24h
  • HbA1C< 12%

Exclusion Criteria:

  • Hemostasis problems
  • Documented hepatic pathology
  • Patient under 18 or over 65 year-old
  • Women with body weight over 70 kg (tolerance of 2 kg between inclusion day and transplantation day) or BMI > 26
  • Men with body weight > 75 kg (tolerance of 3 kg between inclusion day and transplantation day) or BMI > 26
  • insuline needs > 0.7 U/kg/j or 50 U/j
  • Serious life-threatening pathology
  • untreated hyperlipidemia
  • Hypersensitivity to drugs rapamycine-alike
  • Liver disease (transaminases or total bilirubin ≥ 3N)
  • Failure to communicate or cooperate with the investigator

Exclusion criteria that are specific to the use of Rapamycine

  • Hypercholesterolemia (> 350mg/dl, 9,1 mmol/l) not controlled
  • Hypertriglyceridemia (> 500 mg/dl, 5,6 mmol/l) not controlled
  • Leukocytes > 4500 /mm3 , neutrophils > 2000/ mm3, platelets > 100000/ mm3
  • Any clinical or biological pathology that could interfere with the study
  • Past or present neoplasia (with the exception of non melanoma skin cancers)
  • Any hemostasis disorder needing a prolonged treatment with anticoagulation drugs. Low-dose aspirin is permitted.
  • Pregnancy, lactation, pregnancy project or absence of efficient contraception
  • Any medical or psychosocial condition susceptible to interfere with the study, such as drug abuse or recent alcohol abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of insulin-independence at 6 and 12 months after transplantation, duration of insulin-independence, survival curves
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Tolerance (Measurement of portal pressure during islet injection) Quality of life (Questionnaires SF-36 and DQOL at inclusion time, then every 6 months during their waiting period and then 6 months and 12 months after transplantation) Costs
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Pierre Y Benhamou, MD, PhD, University Hospital of Grenoble, Department of Endocrinology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

March 14, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (ESTIMATE)

March 20, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 31, 2010

Last Update Submitted That Met QC Criteria

May 28, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 95/CHUG/10/C2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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